Is the FDA’s antidepressant warning killing people?

The Pediatric Insider

© 2014 Roy Benaroch, MD

In 2004, the FDA launched a program to “strengthen safeguards for children treated with antidepressant medication.” Among other steps, they started requiring manufacturers of several kinds of antidepressants to include a warning in their product labeling, a so-called “black box,” that explicitly and loudly proclaimed a risk for children taking these medications. The warning said that children taking these medications were at an increased risk of suicidal thoughts and behaviors. Later, the black box warning was expanded to include young adults. The warning was required to be added to the labeling of medications including Prozac, Zoloft, Celexa, Wellbutrin, and several other medications.

What prompted this action was an observation from studies of children taking these medications that in the weeks after starting them, there seemed to be increased thoughts of suicide. Not suicide attempts, and not deaths from suicide (there were actually no suicide deaths at all among the study groups), but self-reported thoughts about suicide.

Now, depression is a serious illness—and suicide is a very serious consequence of depression. People with major depression have about a 15% cumulative lifetime risk of death by suicide, so this is a very significant and serious problem not to be taken lightly. We know that people with depression often think of suicide, and are at grave risk for attempting suicide—is it possible that anti-depressant medications actually make this risk worse?

A June, 2014 study from The British Medical Journal has looked at the consequences of the FDA’s decision (and the ensuing broad media coverage.) Researchers examined data from a total of 2.5 million teens and young adults from 11 health care plans in the United States. After the warning, the use of these medications dropped by about 24-31% (depending on age grouping.) This was accompanied by an increase in the rate of suicide attempts, by 22-34%. The rate of deaths from suicide did not change at all—just the rate of attempted suicides.

So, no, the FDA’s warning, based on this study, didn’t increase actual deaths. But it did increase suicide attempts, which likely means it increased the rate and severity and consequences of depression. It certainly hasn’t done any good. The warning has scared many families and doctors away from one mode of therapy for depression. Antidepressant medications aren’t perfect—they do have important side effects, and they don’t always work, and they’re certainly not for everyone with symptoms of depression—but they can be one important part of the treatment of some depressed adolescents. It’s a shame that this misguided “black box warning” is doing more harm than good.

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